TruSeq Custom Amplicon Kit Dx - FFPE QC 20006259

GUDID 00816270020064

DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded (FFPE) tissue. Using the reagents provided in the TruSeq Custom Amplicon Kit Dx, genomic DNA is processed through the library preparation steps, which specifically amplify the intended genomic regions of each sample using analyte specific oligonucleotides, while also adding the indexes and flow cell capture sequences to the amplified products. DNA from whole blood specimens follows the germline workflow, while DNA from FFPE tissue follows the somatic workflow. The resulting sample libraries are ready for sequencing on an Illumina high-throughput DNA sequence analyzer and analysis from instrument software modules that correspond to germline or somatic workflows.

ILLUMINA, INC.

Nucleic acid sequencing reagent kit IVD

• Primary Device ID: 00816270020064
• NIH Device Record Key: 21c7b619-eb5c-4ba4-ab78-d3f09158e27e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruSeq Custom Amplicon Kit Dx - FFPE QC
• Version Model Number: 20006259
• Catalog Number: 20006259
• Company DUNS: 033305264
• Company Name: ILLUMINA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816270020064 [Primary]

FDA Product Code

• PFT: Reagents For Molecular Diagnostic Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-09

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